Rotavirus Vaccine Info
RotaShield, the original vaccine for rotavirus, was a tetravalent reassortant rhesus rotavirus vaccine. After nearly a year in production, it was pulled from the American market when links were drawn between it and intussusception, a condition in which the intestine telescopes in on itself, killing the gut and possibly leading to lethal bacterial infection.
This decision by the American Advisory Committee on Immunization Practices to withdraw its endorsement of the vaccine had large consequences for those suffering from rotavirus diarrhea in developing countries. Not only did the loss of the United States as a market drastically undermine the producer’s ability to make a profit, but also it led to public relations maneuvering within the developing countries to stop supplying the vaccine. After all, what government would want to supply to its people a vaccine deemed too dangerous for the American public?
What such logic did not take into account was the differing levels of risk due to the vaccine in the two settings. In a country such as the United States, in which only 20 to 40 people die per year from rotavirus (Knipe and Howley 1917), the threat of death due to intussusception—however small—was unacceptable. In developing countries around the world, though, the calculus definitely was in favor of continued use of the vaccine (51 deaths due to intussusception/yr vs 500 deaths due to rotavirus gastroenteritis/yr).
Adding to the controversy is the fact that reexamination of the data reveals that the link between intussusception and rotavirus vaccination may not be near as strong as once thought. In 2006, a new, monovalent vaccine called RotaRix was licensed in a number of countries (the US not included), ending the seven year drought of an effective rotavirus vaccine (Knipe and Howley 1956-7). Soon after that, RotaTeq, a human-bovine reassortant, pentavalent, live attenuated, oral vaccine, was approved for use in the United States.
RotaShield, the original vaccine for rotavirus, was a tetravalent reassortant rhesus rotavirus vaccine. After nearly a year in production, it was pulled from the American market when links were drawn between it and intussusception, a condition in which the intestine telescopes in on itself, killing the gut and possibly leading to lethal bacterial infection.
This decision by the American Advisory Committee on Immunization Practices to withdraw its endorsement of the vaccine had large consequences for those suffering from rotavirus diarrhea in developing countries. Not only did the loss of the United States as a market drastically undermine the producer’s ability to make a profit, but also it led to public relations maneuvering within the developing countries to stop supplying the vaccine. After all, what government would want to supply to its people a vaccine deemed too dangerous for the American public?
What such logic did not take into account was the differing levels of risk due to the vaccine in the two settings. In a country such as the United States, in which only 20 to 40 people die per year from rotavirus (Knipe and Howley 1917), the threat of death due to intussusception—however small—was unacceptable. In developing countries around the world, though, the calculus definitely was in favor of continued use of the vaccine (51 deaths due to intussusception/yr vs 500 deaths due to rotavirus gastroenteritis/yr).
Adding to the controversy is the fact that reexamination of the data reveals that the link between intussusception and rotavirus vaccination may not be near as strong as once thought. In 2006, a new, monovalent vaccine called RotaRix was licensed in a number of countries (the US not included), ending the seven year drought of an effective rotavirus vaccine (Knipe and Howley 1956-7). Soon after that, RotaTeq, a human-bovine reassortant, pentavalent, live attenuated, oral vaccine, was approved for use in the United States.
(Source)